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Sebastian Heidenreich and Nicolas Krucien are also minority stockholders in Thermo Fisher Scientific. Janet Kim: employee of Astellas Pharma. Tim Hillard: consultant and speaker for Astellas Pharma. Tommaso Simoncini: consultant for Abbott, Actavis, Applied Medical, Astellas Pharma, Estetra, Gedeon Richter, Johnson & Johnson, Medtronic, Mitsubishi Tanabe and Sojournix; speaker for Abbott, Applied Medical Gedeon Richter, Intuitive Surgical, Shionogi and Theramex. Janet Walker and Clarissa Kristjansson: none to declare.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Details for how researchers may request access to anonymised participant level data, trial level data and protocols from Astellas sponsored clinical trials can be found at\n                      \n                      .","order":2,"name":"Ethics","label":"Availability of data and material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval of this study was granted by Salus IRB (Salus institutional review board study no. 22089-01).","order":3,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Electronic informed consent was obtained from all participants.","order":4,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"SH, TS, KC, JK, LT, JW, CK and TH were involved in the planning and design of the trial. SH and KC were involved in acquisition of the data. SH, KC, NK, JK and LT contributed to analysis of the data. SH, TS, KC, NK, LT, JW, CK and TH were involved in the interpretation of the data. All authors contributed to the writing of the report, had full access to all of the results and can confirm the accuracy and completeness of the data reported.","order":6,"name":"Ethics","label":"Author contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}